Reported Sep 21, 2022 · Terminated

BIOPHEN UFH Control Plasma

Aniara Diagnostica LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Aniara Diagnostica LLC · 7768 Service Center Dr · West Chester, OH · 45069-2442

Is this the product you have?

  • BIOPHEN UFH Control Plasma
Lot codes and dates
  • UDI-DI (GTIN)03663537008290 Reference No.: 223101
  • Lot CodeFA2035
Amount recalled
13 units (1 unit is 1 box)

Where it was sold

Why it was recalled

Incorrect product labeling was included in the package.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 18, 2024 · Data as of Sep 19, 4:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.